Bioprocess PD Engineer: Validation & Tech Transfer

Amgen; Holly Springs (NC); On-site; USD 88,000 - 119,000; Full time

Benefits offered by this job

Retirement plan

Stock-based incentives

Generous time-off

Flexible work models

Job summary

Amgen is seeking a PD Engineer to join the Process Development Drug Substance Technology group within the PBS team at its FleX Batch Biologics Manufacturing Facility. You will contribute to process validation, tech transfer, and bioburden assessments across upstream and downstream operations to ensure compliant, scalable manufacturing of drug substances.

The role requires multiple pathways of biologics process development or validation support, strong communication, and collaboration with

Qualifications

• High school diploma / GED and 8 years of biologics process development or process validation support experience
• Associate’s degree and 6 years of biologics process development or process validation support experience
• Bachelor’s degree and 2 years of biologics process development or process validation support experience
• Master’s degree

Responsibilities

• Support bioburden impact assessment and assess unit operation capability to remove microorganisms or potential by-products and provide operational and engineering advice as part of the overall assessment
• Apply a fundamental understanding of Upstream (Cell Culture) and Downstream (Purification) bioprocessing to provide risk-based approach to microbial assessments
• Work cross-functionally to support microbial impact assessment drafts and documentation review
• Perform trending of bioburden instances within manufacturing space and elevate concerning objectionable microorganisms
• Provide guidance for the generation, resolution and closure of deviations
• Support upstream and/or downstream process engineering teams for process monitoring or technical study activities
• Provide process validation support as required for documentation or floor activities
• Support ANC PD business strategy activities to improve network practice, develop digital tools, and optimize the ANC PD business operations

Skills

Upstream (Cell Culture)

Downstream (Purification)

Process Validation

Biopharmaceutical manufacturing

cGMP compliance

Education

High school diploma / GED

Associate’s degree

Bachelor’s degree

Master’s degree

Job description

Amgen is seeking a PD Engineer to join the Process Development Drug Substance Technology group within the PBS team at its FleX Batch Biologics Manufacturing Facility. You will contribute to process validation, tech transfer, and bioburden assessments across upstream and downstream operations to ensure compliant, scalable manufacturing of drug substances.

The role requires multiple pathways of biologics process development or validation support, strong communication, and collaboration with